Today the FDA external advisory committee, called VRBPAC, met to discuss and vote on the safety and effectiveness of two COVID19 vaccines (Moderna and Pfizer) for under 5 year olds. Many of us parents have been waiting a long time for this! Ultimately, the committee unanimously voted to approve both vaccines.
I have been vaccinated and boosted. I most enjoy the MRNA technology. I read through each of the data sets and graphs - including higher rates of hospitialization. I have not seen a clean statement of reduced risk, more importantly a projection of reduced risk giving children a vaccine designed to protect against an older version of COVID. The antibody activity is fine, we know the key for adults is now the impact on T and B cells of the immune system. Everyone fails to acknowledge the lack of longitudinal data and for low probability events - they will not show in small clinical trials. The vaccines for children may work great - the data available is limited. This should be made clear up front. We are going to give vaccines for old variants of covid - we dont' give children vaccines for old variants of the flu
Having closely followed the roll out here in Australia, I don't feel reassured by your words. Here's a short clip of a very nervous Queensland Chief Health Officer Dr John Gerrard telling us they're "keeping a close eye" on reports of people dying suddenly from myocarditis after a short illness: https://rumble.com/vwhgw9-australian-health-official-vaxed-are-dying-from-myocarditis.html
Note how he corrects himself from "a few" reports to "reports". Months before this press conference, it was reported in our media that two Australian journalists were hospitalised for myocarditis following pfizer (Georgia Clark and Denham Hitchock). Denham Hitchock's case certainly wasn't mild and we don't know if there's permanent scarring that could increase his risk of chronic heart failure in the future.
A couple of reporters shout out, asking if it's the vaccines but D'Ath dismisses them, saying "Vaccines actually help people stay out of hospital".
Here are testimonials from ICU nurses (general and cardiac) at a Health and Welfare Meeting of the Louisiana House of Reps about the "terrifying" injuries they're seeing from these shots. The nurses all say the injuries are not being reported to VAERS. They speak at the one hour mark: https://house.louisiana.gov/H_Video/VideoArchivePlayer?v=house/2021/nov/1108_21_HW
In this climate of fierce censorship, you'll get a better idea of what's going on by physically going to places yourself or ringing people up and speaking to them directly. You can contact Monte Vista school in CAL; they have 4 cases of myocarditis following the shots in approx 800 students (presumably 50% boys.)
The rate at Monte Vista fits what I've seen in this city of Melbourne, Australia. I don't know that many people but I know two young men (aged 20) who are friends who both got myocarditis after pfizer. They're being seen by the same cardiologist. Neither case is mild. Their prognosis is unknown.
Despite the censorship, you can still find studies that report a higher incidence of myocarditis from the Covid shots. When the study by Patone et al. was redone according to age and gender, investigators found a higher rate of myocarditis in jab recipients skewed to younger males.
As for heart inflammation from the mRNA shots being mild and rare, Ernest Ramirez's son Ernesto aged 16 died after pfizer. Mr. Ramirez didn't know there was any risk of death. He was offered money to keep quiet but refused. There are other cases such as that of Sean Hartman.
Published studies have found permanent damage to hearts following the mRNA shots in the form of fibrosis (Bozkurt et al) and necrosis (Matta et al.), so it's reasonable to think that in some cases extensive damage could lead to death.
You recommend Moderna over Pfizer. We know males of younger age are more at risk of heart inflammation from the mRNA shots and there's a higher risk with Moderna (Sweden, Norway and Finland halted Moderna in under 30s). I therefore don't understand your logic that myocarditis could be less common in the youngest age group, particularly when you're advocating Moderna.
We know the trials in adults were under powered to detect myocarditis but that it still occurred in the real world. There are over 1000 peer-reviewed papers on other adverse effects from the Covid shots, such as transverse myelitis that appeared on FDA slides in December 2020 and is listed in pfizer's postmarketing experience document.
Even without extensive real world data on injuries, there were major red flags in the original RCTs:
Compare the NEJM report with the FDA one on the Pfizer trial for ages 12-15. Do you know the reasons for the discrepancy in numbers of children who didn't receive a second dose? Do you know the reasons why these children didn't get a second dose?
Brianne Dressen's severe neurological AE was censored from the AZ trial because it occurred after one dose. There's every reason to suspect that could have gone on in the Pfizer trial. Moreover, both Brianne and Stephanie de Garay (whose daughter Maddie was paralysed on the pfizer trial) say trial participants could only report AEs by choosing from a pre-specified list of minor ones.
I question the reliability of any source that makes statements I consider disingenuous. You said Pfizer reporting scalding from coffee (nothing to do with their drug) was an example of rigour. You neglect to mention they passed off a case of paralysis in a child aged twelve as a stomach ache in their published report. It's blatant fraud and criminally negligent not to investigate such a severe case before rolling out to healthy children.
You're strongly urging parents to give their babies and toddlers what the FDA in 2020 considered to be experimental (the EUA document calls the Covid vaccines "investigational") gene therapy (Moderna's SEC filing document from April 2020 states the FDA considered mRNA to be gene therapy.)
If a product is marketed as a vaccine, then certain safety studies don't need to be done; studies in carcinogenicity and genotoxicity were not done because the drug was not "expected' to have an adverse effect in this regard, as you can see on page 29 of Pfizer's document:https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf
Clinical trials to determine safety in reproductive health are ongoing. You may be aware that menstrual irregularities have been reported globally, including in the BMJ. There are two reports of vaginal haemorrhaging in a woman and a child aged 11 on the TGA DAEN website. The child appears on page 35. Note the rat bleeding on the vulva that was euthanized (page 55) in the pfizer study:
Note also how much of this animal study in safety is redacted. As a parent, does any of this concern you?
The covid inoculations don't reduce transmission at all. The only reason to give these mRNA drugs to children would be to reduce their risk of a severe outcome. Where's the evidence, even in the original clinical trials in adults for the original variant, that they reduce the risk of a severe outcome?
These drugs are, at best, a symptom mitigator with a limited window of efficacy.
I'm happy for all those families with little ones who have waited so long. Congratulations :)
Vaccination, even against the original coronavirus, seems to be holding up as our best option against new variants, long Covid, reinfection, and longer term bad stuff that gets discussed by thought leaders on sites like twitter.
I will definitely be recommending vaccination with the existing mRNA vaccines for this age group as an imperfect, better-late-than-never imperative. Thanks for the unofficial tilt towards Moderna over Pfizer in the <5 yo's.
Anticipating a bivalent (including Omicron) booster in the fall for adults and kids most likely, and I'm tilting towards mixing and matching boosters.
Curious on the challenges in speeding up vaccines with updated instructions? Previously (going all the way back to January 2021 which feels like 10 years ago) in your piece "Vaccines are made with mutations in mind" [1] you noted:
>"However, if a random mutation did render a vaccine useless, the mRNA instructions are incredibly easy to change. This is the beauty of this type of vaccine. It’s like editing a Word document; just tweaking the code a little. And, the FDA wouldn’t need Phase I-III trials again. This is because the code isn’t changed enough to concern safety or efficacy. They would just need to see a study with a few dozen people that showed the new code produced satisfactory amounts of antibodies and protection against the mutated virus." <
Can you elaborate on what hasn't made this a reality? It seems we will be getting Omicron specific vaccine nearly a year after it appeared, give or take a few months. Seems plausible by that time we will be on a new greek letter or sub-sub-variant.
The 6-11 cohort never cracked 30% vaccination rates, I suspect we won't cross half that for the <5 group for similar reasons the older group enthusiasm waned.
Thank you, as always. I appreciate your advice and am ready to sign my son up for Moderna. However, he will be turning 5 before he can receive his second dose. He turns 5 two weeks after we expect the vaccines to become available. Do I get him a dose of the Moderna anyway? In the past, you have suggested vaccinating as soon as possible. But wondering about this. Does he mix vaccines? Or go with the low dose Pfizer, that is a 3 course shot... but what happens when he turns five?
Thank you as always! Can you confirm that the data around hospitalizations and deaths in children under 5 is from COVID vs with COVID? One of the source links from the PPT goes to a dead link on the CDC website and the one that I was able to access doesn't show how they define that metric so it's not clear. The infection rate of COVID is high so it's not unreasonable to think that people in hospitals are testing positive even if they're asymptomatic and in the hospital for non-COVID related issues.
Thank you so much for this information! Can I ask you about your opinion on Moderna vs. Pfizer for a 18-month old? I definitely see your points about Moderna's advantages. My only worry is that Moderna's dose may be too large for such a small child. Or do you think the benefits outweigh my concern? Put differently, if your girls were 18-months old, would you still pick Moderna for them?
My kids got omicron just after your family did - will you be spacing out the second Moderna dose? I'm sort of thinking their first dose will provide decent (temporary) protection since they had an infection, and perhaps the second dose 6-8 weeks after may provide more durable immunity vs. getting it right at 4 weeks?
Thank you for this post! Is there info on what level of efficacy is reached after just the first Moderna dose? We have relatives itching to interact this summer and I want to get a better idea of the risks during the "in-between" phase of Moderna doses.
I have a newly minted 5 year old who is supposed to get his Pfizer vaccine this weekend. Thoughts on whether to hold off for a few days to get him the little kid moderna instead?
Agree that little kid Pfizer seems less good than little kid moderna. But any extrapolated opinions on big kid Pfizer compared to little kid moderna?
Hi Katelyn, do you suggest mixing moderna and pfizer for the under fives? My son is one and had his first dose of pfizer. I want him to have optimal protection and have heard you can mix and match as long as he gets three doses (I.e. Pfizer, moderna, moderna or pfizer, pfizer, pfizer, or pfizer, moderna, pfizer). Do you recommend this? I’m having trouble finding information about this for kids. The place my son gets vacations offers both moderna and pfizer. I didn’t understand the data comparing the two vaccines and opted for the initial pfizer dose. Thanks!
Not sure if this is the place to write this comment but I am kind of freaking out. Mom of 3 here. Just took my 2.5 year old to get her fist COVID vaccine. And found out after the shot that we accidentally got phizer instead of the moderna shot we so wanted for her. I don’t know why I didn’t double check before he gave her the shot. So so upset and wondering what the best thing to do at this point is.
Can I switch her to Moderna at this point? And still get two moderna vaccines? I’m guessing the answer is no. Should I just stick to getting her the rest of the phizer series? I really wanted her to have better coverage that moderna offers. Her father and brother have a rare genetic blood disorder that may put them at increased risk for severe illness/hospitalization. I am just so upset about this. Any information you can share would be appreciated so much. Thanks in advance!
Thank you so much for this great summary, as always. I can finally vaccinate my 3-yr old. As of my 6 yr-old, should I get her boosted with Moderna if she had Pfizer? (I mixed my booster (Mod-Mod-Pfizer)
FDA meeting for <5 COVID vaccine: Q&A
I have been vaccinated and boosted. I most enjoy the MRNA technology. I read through each of the data sets and graphs - including higher rates of hospitialization. I have not seen a clean statement of reduced risk, more importantly a projection of reduced risk giving children a vaccine designed to protect against an older version of COVID. The antibody activity is fine, we know the key for adults is now the impact on T and B cells of the immune system. Everyone fails to acknowledge the lack of longitudinal data and for low probability events - they will not show in small clinical trials. The vaccines for children may work great - the data available is limited. This should be made clear up front. We are going to give vaccines for old variants of covid - we dont' give children vaccines for old variants of the flu
"...but data will be closely followed".
Having closely followed the roll out here in Australia, I don't feel reassured by your words. Here's a short clip of a very nervous Queensland Chief Health Officer Dr John Gerrard telling us they're "keeping a close eye" on reports of people dying suddenly from myocarditis after a short illness: https://rumble.com/vwhgw9-australian-health-official-vaxed-are-dying-from-myocarditis.html
Note how he corrects himself from "a few" reports to "reports". Months before this press conference, it was reported in our media that two Australian journalists were hospitalised for myocarditis following pfizer (Georgia Clark and Denham Hitchock). Denham Hitchock's case certainly wasn't mild and we don't know if there's permanent scarring that could increase his risk of chronic heart failure in the future.
Here's Queensland Minister of Health and Ambulance Services Yvette D'Ath reporting on a 40% rise in call outs for cardiac arrests, chest pains and respiratory issues:https://rumble.com/v10uifl-queensland-health-minister-cant-explain-sudden-40-heart-attacks-chest-pains.html
A couple of reporters shout out, asking if it's the vaccines but D'Ath dismisses them, saying "Vaccines actually help people stay out of hospital".
Here are testimonials from ICU nurses (general and cardiac) at a Health and Welfare Meeting of the Louisiana House of Reps about the "terrifying" injuries they're seeing from these shots. The nurses all say the injuries are not being reported to VAERS. They speak at the one hour mark: https://house.louisiana.gov/H_Video/VideoArchivePlayer?v=house/2021/nov/1108_21_HW
In this climate of fierce censorship, you'll get a better idea of what's going on by physically going to places yourself or ringing people up and speaking to them directly. You can contact Monte Vista school in CAL; they have 4 cases of myocarditis following the shots in approx 800 students (presumably 50% boys.)
The rate at Monte Vista fits what I've seen in this city of Melbourne, Australia. I don't know that many people but I know two young men (aged 20) who are friends who both got myocarditis after pfizer. They're being seen by the same cardiologist. Neither case is mild. Their prognosis is unknown.
Despite the censorship, you can still find studies that report a higher incidence of myocarditis from the Covid shots. When the study by Patone et al. was redone according to age and gender, investigators found a higher rate of myocarditis in jab recipients skewed to younger males.
As for heart inflammation from the mRNA shots being mild and rare, Ernest Ramirez's son Ernesto aged 16 died after pfizer. Mr. Ramirez didn't know there was any risk of death. He was offered money to keep quiet but refused. There are other cases such as that of Sean Hartman.
Published studies have found permanent damage to hearts following the mRNA shots in the form of fibrosis (Bozkurt et al) and necrosis (Matta et al.), so it's reasonable to think that in some cases extensive damage could lead to death.
You recommend Moderna over Pfizer. We know males of younger age are more at risk of heart inflammation from the mRNA shots and there's a higher risk with Moderna (Sweden, Norway and Finland halted Moderna in under 30s). I therefore don't understand your logic that myocarditis could be less common in the youngest age group, particularly when you're advocating Moderna.
We know the trials in adults were under powered to detect myocarditis but that it still occurred in the real world. There are over 1000 peer-reviewed papers on other adverse effects from the Covid shots, such as transverse myelitis that appeared on FDA slides in December 2020 and is listed in pfizer's postmarketing experience document.
There are websites where you can listen to and read testimonials from people who have been injured by these shots: https://www.realnotrare.com/ https://www.nomoresilence.info/ https://www.jabinjuriesglobal.com/ and a physician led one: https://react19.org/
Even without extensive real world data on injuries, there were major red flags in the original RCTs:
Compare the NEJM report with the FDA one on the Pfizer trial for ages 12-15. Do you know the reasons for the discrepancy in numbers of children who didn't receive a second dose? Do you know the reasons why these children didn't get a second dose?
Brianne Dressen's severe neurological AE was censored from the AZ trial because it occurred after one dose. There's every reason to suspect that could have gone on in the Pfizer trial. Moreover, both Brianne and Stephanie de Garay (whose daughter Maddie was paralysed on the pfizer trial) say trial participants could only report AEs by choosing from a pre-specified list of minor ones.
I question the reliability of any source that makes statements I consider disingenuous. You said Pfizer reporting scalding from coffee (nothing to do with their drug) was an example of rigour. You neglect to mention they passed off a case of paralysis in a child aged twelve as a stomach ache in their published report. It's blatant fraud and criminally negligent not to investigate such a severe case before rolling out to healthy children.
You're strongly urging parents to give their babies and toddlers what the FDA in 2020 considered to be experimental (the EUA document calls the Covid vaccines "investigational") gene therapy (Moderna's SEC filing document from April 2020 states the FDA considered mRNA to be gene therapy.)
If a product is marketed as a vaccine, then certain safety studies don't need to be done; studies in carcinogenicity and genotoxicity were not done because the drug was not "expected' to have an adverse effect in this regard, as you can see on page 29 of Pfizer's document:https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf
Clinical trials to determine safety in reproductive health are ongoing. You may be aware that menstrual irregularities have been reported globally, including in the BMJ. There are two reports of vaginal haemorrhaging in a woman and a child aged 11 on the TGA DAEN website. The child appears on page 35. Note the rat bleeding on the vulva that was euthanized (page 55) in the pfizer study:
https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
Note also how much of this animal study in safety is redacted. As a parent, does any of this concern you?
The covid inoculations don't reduce transmission at all. The only reason to give these mRNA drugs to children would be to reduce their risk of a severe outcome. Where's the evidence, even in the original clinical trials in adults for the original variant, that they reduce the risk of a severe outcome?
These drugs are, at best, a symptom mitigator with a limited window of efficacy.
I'm happy for all those families with little ones who have waited so long. Congratulations :)
Vaccination, even against the original coronavirus, seems to be holding up as our best option against new variants, long Covid, reinfection, and longer term bad stuff that gets discussed by thought leaders on sites like twitter.
I will definitely be recommending vaccination with the existing mRNA vaccines for this age group as an imperfect, better-late-than-never imperative. Thanks for the unofficial tilt towards Moderna over Pfizer in the <5 yo's.
Anticipating a bivalent (including Omicron) booster in the fall for adults and kids most likely, and I'm tilting towards mixing and matching boosters.
A good week for Moderna and kids <17:
https://www.medscape.com/viewarticle/975594#vp_1
Katelyn -
Curious on the challenges in speeding up vaccines with updated instructions? Previously (going all the way back to January 2021 which feels like 10 years ago) in your piece "Vaccines are made with mutations in mind" [1] you noted:
>"However, if a random mutation did render a vaccine useless, the mRNA instructions are incredibly easy to change. This is the beauty of this type of vaccine. It’s like editing a Word document; just tweaking the code a little. And, the FDA wouldn’t need Phase I-III trials again. This is because the code isn’t changed enough to concern safety or efficacy. They would just need to see a study with a few dozen people that showed the new code produced satisfactory amounts of antibodies and protection against the mutated virus." <
Can you elaborate on what hasn't made this a reality? It seems we will be getting Omicron specific vaccine nearly a year after it appeared, give or take a few months. Seems plausible by that time we will be on a new greek letter or sub-sub-variant.
The 6-11 cohort never cracked 30% vaccination rates, I suspect we won't cross half that for the <5 group for similar reasons the older group enthusiasm waned.
[1] https://yourlocalepidemiologist.substack.com/p/vaccines-are-made-with-mutations-in-mind?s=r
Thank you, as always. I appreciate your advice and am ready to sign my son up for Moderna. However, he will be turning 5 before he can receive his second dose. He turns 5 two weeks after we expect the vaccines to become available. Do I get him a dose of the Moderna anyway? In the past, you have suggested vaccinating as soon as possible. But wondering about this. Does he mix vaccines? Or go with the low dose Pfizer, that is a 3 course shot... but what happens when he turns five?
Thanks for any advice.
I am struggling to find evidence to support this snippet:
> By the end of summer, Moderna kids will likely be on the same playing field as adults, who will likely get a bivalent vaccine this fall.
It sounds as if Moderna is testing a bivalent booster, but for adults. How will that be rolled out to the under 5s? Why are you confident it will be?
Thank you as always! Can you confirm that the data around hospitalizations and deaths in children under 5 is from COVID vs with COVID? One of the source links from the PPT goes to a dead link on the CDC website and the one that I was able to access doesn't show how they define that metric so it's not clear. The infection rate of COVID is high so it's not unreasonable to think that people in hospitals are testing positive even if they're asymptomatic and in the hospital for non-COVID related issues.
Thank you so much for this information! Can I ask you about your opinion on Moderna vs. Pfizer for a 18-month old? I definitely see your points about Moderna's advantages. My only worry is that Moderna's dose may be too large for such a small child. Or do you think the benefits outweigh my concern? Put differently, if your girls were 18-months old, would you still pick Moderna for them?
My kids got omicron just after your family did - will you be spacing out the second Moderna dose? I'm sort of thinking their first dose will provide decent (temporary) protection since they had an infection, and perhaps the second dose 6-8 weeks after may provide more durable immunity vs. getting it right at 4 weeks?
Thank you for this post! Is there info on what level of efficacy is reached after just the first Moderna dose? We have relatives itching to interact this summer and I want to get a better idea of the risks during the "in-between" phase of Moderna doses.
Thank you for this!
I have a newly minted 5 year old who is supposed to get his Pfizer vaccine this weekend. Thoughts on whether to hold off for a few days to get him the little kid moderna instead?
Agree that little kid Pfizer seems less good than little kid moderna. But any extrapolated opinions on big kid Pfizer compared to little kid moderna?
Thank you again. You are a gifted communicator.
Hi Katelyn, do you suggest mixing moderna and pfizer for the under fives? My son is one and had his first dose of pfizer. I want him to have optimal protection and have heard you can mix and match as long as he gets three doses (I.e. Pfizer, moderna, moderna or pfizer, pfizer, pfizer, or pfizer, moderna, pfizer). Do you recommend this? I’m having trouble finding information about this for kids. The place my son gets vacations offers both moderna and pfizer. I didn’t understand the data comparing the two vaccines and opted for the initial pfizer dose. Thanks!
Not sure if this is the place to write this comment but I am kind of freaking out. Mom of 3 here. Just took my 2.5 year old to get her fist COVID vaccine. And found out after the shot that we accidentally got phizer instead of the moderna shot we so wanted for her. I don’t know why I didn’t double check before he gave her the shot. So so upset and wondering what the best thing to do at this point is.
Can I switch her to Moderna at this point? And still get two moderna vaccines? I’m guessing the answer is no. Should I just stick to getting her the rest of the phizer series? I really wanted her to have better coverage that moderna offers. Her father and brother have a rare genetic blood disorder that may put them at increased risk for severe illness/hospitalization. I am just so upset about this. Any information you can share would be appreciated so much. Thanks in advance!
Thank you so much for this great summary, as always. I can finally vaccinate my 3-yr old. As of my 6 yr-old, should I get her boosted with Moderna if she had Pfizer? (I mixed my booster (Mod-Mod-Pfizer)
Thank you! I think my 3 year old granddaughter will be getting Moderna also. Finally!